STEP Trial for Heel Fat Pad Syndrome (STEP)

  • STATUS
    Recruiting
  • End date
    Mar 7, 2023
  • participants needed
    19
  • sponsor
    Northwestern University
Updated on 7 June 2022

Summary

The primary objectives of this study are to investigate the immediate and short-term effect of heel fat pad loop taping (experimental intervention) vs. control taping (control intervention) on pain and function in individuals with heel fat pad syndrome (HFPS). For mechanistic understanding of the effect of the loop taping, we will assess the immediate effect of taping on the pressure pain threshold and heel fat pad thickness.

Description

The study objectives are to investigate the immediate and short-term effect of heel fat pad loop taping (experimental intervention) vs. control taping (control intervention) on pain and function in individuals with heel fat pad syndrome (HFPS). We hypothesize that the fat pad loop taping is superior to control taping in immediate and short-term pain reduction and short-term function and mobility improvement. To understand potential mechanisms underlying the benefits of the looping taping, we will assess the immediate effect of taping on the pressure pain threshold and heel fat pad thickness. We hypothesize that applying fat pad loop taping will increase the pressure pain threshold (i.e., diminished pain sensitivity) recorded by a mechanical pressure algometer and increase fat pad thickness quantified by ultrasound. Despite being the second leading cause of plantar heel pain, RCTs for conservative management do not exist. Findings of this proposed project will provide much-needed evidence on effective non-pharmacological managements of HFPS.

Details
Condition Heel Fat Pad Syndrome
Treatment Loop taping, Control taping
Clinical Study IdentifierNCT05385796
SponsorNorthwestern University
Last Modified on7 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men or women 18 to 79 years of age
History of plantar heel pain in either foot for at least one week and less than 3 years before enrollment
Tenderness on palpation of the heel fat pad
Self-reported worst unilateral or bilateral central heel pain of ≥ 3 on a 0-10 Numeric Pain Rating Scale (NPRS) during the past week
Pain ≥ 3 on NPRS during at least one of two pain-aggravating activities of 30-sec static single leg standing OR barefoot 20-meter walking assessed during the enrollment screening and before the tape application

Exclusion Criteria

Primary diagnoses of plantar heel pain (e.g., plantar fasciopathy, posterior tibialis tendinopathy, or tarsal tunnel syndrome) other than HFPS
Ultrasound-measured plantar fascia thickness ≥ 4mm, combined with clinical presentations of plantar fasciopathy
BMI ≥ 35
Systemic inflammatory arthritis
Diabetes
Lumbar radiculopathy
Neurological conditions affecting gait and mobility
Having received taping for HFPS within the last month
Prior heel surgery
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